Fluoroquinolones and Tendon Ruptures/Muscle Weakness
Levaquin, Cirpo and Avelox are dangerous antibiotics which are overprescribed and overpromoted. A few doses of these drugs can cause spontaneous rupture of one or both Achilles tendons. These ruptures can so alter the integrity of the tendon as to make surgical repair impossible.
On July 8, 2008, the FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. See FDA Alert.
Furthermore, the FDA advised that Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy.
The Geriatric Use subsection of the label, which previously said nothing about the increased risk for tendon injury in this population, was updated in 2007 as follows:
Patients over 65 are at increased risk for developing severe tendon disorders including tendon rupture when being treated with a fluoroquinolone such as LEVAQUIN. This risk is further increased with age concomitant steroid therapy. Tendon rupture usually involved the Achilles, hand or shoulder tendons and can occur during therapy or up to a few months post completion of therapy. Caution should be used when prescribing levofloxacin to elderly patients especially those on corticosteroids.
The current labeling for Levaquin presently warns that "ruptures of the shoulder, hand, Achilles tendon, or other tendons that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin."
Such warning was a result of a petition by Public Citizen on August 29, 2006, to Andrew Von Eschenbach, M.D., then acting FDA Commissioner, requesting that the FDA strengthen its warning with respect to fluroquinolones such as Levaquin.
According to Public Citizen's assessment, data from the FDA's Adverse Event database from November 1997 to December 2005, indicated that "a total of 61% of fluroquinolone-associated ruptures were associated with levofloxacin," significantly higher than any of the other drugs in this class."
Additional data submitted by Public Citizen "revealed that the FDA had received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics." Since this Petition, an additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336.
As of January 2008, the FDA has failed to respond to a number of requests for a strengthened Black Box Warning relating to Levaquin and the risk of tendon ruptures.
In fact, Public Citizen has recently sought legal action for such strengthened labeling for Levaquin before the United States District Court for the District of Columbia, with goal of compelling "the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled."
Furthermore, last December, Ortho McNeil-Janssen Pharmaceuticals added new labeling to Levaquin. This updated black box warning states that "Fluoroquinolones, including Levaquin, may exacerbate muscle weakness in persons with myasthenia gravis," a neuromuscular disorder. Levaquin and other fluoroquinolones have neuromuscular blocking activity and have been linked to serious adverse events in patients with myasthenia gravis, including ventilatory support and deaths. This warning is in addition to the July 2008 Black Box warning concerning the increased risk of tendon ruptures and tendonitis.
There is no question that Levaquin is an important antibiotic that saves lives. That is all the more reason to make sure that the drug is properly labeled to warn physicians and patients of the serious and deadly risks associated with it. Clearly, patient with myasthenia gravis should not be prescribed this drug. And Levaquin should not be a first line treatment for many infections; especially now when more and more infections are becoming resistant to stronger and newer antibiotics, while other antibiotics may carry fewer risks.
If you or a loved one suffered a tendon injury during or immediately after taking Levaquin, you should immediately contact the attorneys at Pogust Braslow & Millrood, where Protecting Consumers Is Our Primary Goal. Just fill out this form, click here to send us an email or call us at (610) 941-4204.
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